Identity
- Trade Name
- WK-56 LT S EUDAMEDFDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Rotary Handpieces R&P EUDAMEDSynea Vision Handpiece 1:1 FDA UDI
- Model / Reference
- 30217000 EUDAMEDFDA UDI
- Description
- Synea Vision Handpiece 1:1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- +J021302170001 EUDAMEDJ021302170001 FDA UDI
- Basic UDI-DI
- ++J021RP0002QA EUDAMED
- Direct Marketing DI
- +J021302170000 EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental surgical power tool motorized handpiece/set, electric
Wk-56 Lt S by W & H Dentalwerk Bürmoos GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (2)
- FDA UDI 937eb255-1e06-40c1-8092-d7259bac8dc1 33 fields · synced Oct 7, 2026
- EUDAMED 9d6b2027-0e32-4ea9-b534-8b729e20aebd 61 fields · synced Oct 7, 2026